Olita is the first domestically developed target therapy for lung cancer and is used to treat patients with epidermal growth factor receptor (EGFR)-T790M mutation-positive non-small cell lung cancer (NSCLC).

The phase 2 clinical trial prescribed Olita to 162 patients with advanced T790M mutation-positive NSCLC, including patients with brain metastasis. The trial found no significant difference in progression-free survival (PFS) period between patients with and without brain metastases, suggesting that Olita is equally effective for patients with brain metastases.

According to the results of the study, the PFS and overall survival (OS) period were 9.4 and 19.7 months, respectively, for both groups. Adverse events included diarrhea, nausea, and rash, which were controllable by reducing the dosage.

“The trial has confirmed that Olita can treat patients with T790M mutation-positive NSCLC that also have brain metastases,” said Park Keun-chil 박근칠, head of the trial and a professor at Samsung Medical Center’s 삼성서울병원 hematology and oncology department. “Olita showed promising future as a third-generation lung cancer drug as it showed positive PFS results, which is an important indicator for evaluating the efficacy of anticancer drugs.”

The phase 2 trials will provide the basis for the upcoming phase 3 trials that aim to prove the efficacy and safety of the drug in both the existing 800-milligram dosage and other low-dosage groups, Park added

“The results of the clinical trial showed that Olita has the potential to succeed in the global market,” said Kwon Se-chang 권세창, CEO of Hanmi Pharmaceuticals 한미약품. “The company will concentrate all of its capabilities in developing innovative therapies for patients who have cancer.”